The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
- Conditions
- Secondary Hypogonadism
- Interventions
- Drug: Androxal (enclomiphene citrate)
- Registration Number
- NCT01386606
- Lead Sponsor
- Repros Therapeutics Inc.
- Brief Summary
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.
- Detailed Description
Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
- Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
- All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
- Agreement to use a condom, and with a fertile female partner, another form of contraception.
- Agreement to provide a semen sample in the clinic
- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
- Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
- Use of Clomid in the past year or during the study
- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
- A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
- Clinically significant abnormal findings on screening examination
- Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
- Known hypersensitivity to Clomid
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
- Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
- History of breast cancer
- History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA >3.6
- History of known hyperprolactinemia with or without a tumor
- Chronic use of medications use such as glucocorticoids
- Chronic use of narcotics
- Subjects known to be positive for HIV
- Subjects with end stage renal disease
- Subjects with cystic fibrosis (mutation of the CFTR gene)
- Subjects unable to provide a semen sample in the clinic
- Subject has a BMI >42 kg/m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Androxal 25 mg Androxal (enclomiphene citrate) Androxal 25 mg/day Androxal 12.5 mg Androxal (enclomiphene citrate) Androxal 12.5 mg/day Androxal 6.25 mg Androxal (enclomiphene citrate) Androxal 6.25 mg/day AndroGel Testosterone AndroGel 5G topical testosterone
- Primary Outcome Measures
Name Time Method 24 Hour Average and Maximum Testosterone Concentration Baseline and Week 6 The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.
Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
- Secondary Outcome Measures
Name Time Method Change in Leuteinizing Hormone (LH) Baseline, Week 2, Week 4, Week 6 Changes in morning LH after continuous dosing
Change in Follicle Stimulating Hormone (FSH) Baseline, Week 2, Week 4, Week 6 Changes in morning FSH after continuous dosing
Trial Locations
- Locations (2)
Cetero Research
🇺🇸San Antonio, Texas, United States
Centex Research
🇺🇸Houston, Texas, United States